Investigations related to products or pipeline candidates by regulatory authorities are a major overhang for companies and create uncertainty until the issue is resolved. Earlier this week, AstraZeneca (AZN) received some encouraging news when the U.S. Department of Justice confirmed that it is closing its investigation on the PLATO trial, on the basis of which blood-thinner Brilinta was approved. The government does not plan to take any further action.
We remind investors that on Oct 21, 2013, AstraZeneca had received a civil investigative demand from the Department of Justice looking for documents and information related to the PLATO study.
AstraZeneca’s Brilinta is available for reducing cardiovascular death and heart attack in patients suffering from acute coronary syndrome (ACS) since it was approved in the U.S. in 2011. The FDA had cleared the drug on the basis of the PLATO study which compared Brilinta to Sanofi’s (SNY) Plavix in 18,624 patients suffering from ACS.
AstraZeneca is looking to broaden Brilinta’s label. Several studies on Brilinta are ongoing including SOCRATES (acute ischemic stroke or transient ischemic attack), THEMIS (type II diabetes and coronary atherosclerosis), EUCLID (peripheral artery disease) and PEGASUS (secondary prevention in patients with previous myocardial infarction – headline results expected in the first quarter of 2015). The company has completed enrollment for EUCLID and PEGASUS. We note that all four studies are part of the PARTHENON program on Brilinta.
Our Take
We are pleased with the favorable conclusion of the PLATO study investigation. Brilinta is one of the key new products at the company. In the first half of 2014, the product generated revenues of approximately $216 million, up 84% year over year. The company is working on driving Brilinta sales.
AstraZeneca presently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Endo International (ENDP) and Allergan (AGN). Both are Zacks Rank #1 (Strong Buy) stocks.
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